Lupin and Mylan on Friday (27 March) announced Positive European Medicines Agency opinion recommending approval of Nepexto, a biosimilar to Etanercept.
Lupin and Mylan N.V. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.The positive CHMP opinion is based on a biosimilarity assessment which included preclinical and clinical studies demonstrating bioequivalence to the reference product. In addition, a phase 3 clinicalstudyiin patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to the reference product in terms of efficacy, safety and immunogenicity.
The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for member countries of the EU. The decision on the EC's approval is expected in May 2020.
Enbrel had sales of approximately $9.6 billion globally for the 12 months ending December 2019, according to IQVIA.
In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets.
Etanercept is an injectable, biologic medicine which inhibits Tumour Necrosis Factor (TNF). TNF is a key cytokine involved in the pro-inflammatory cascade in many chronic, immune-mediated inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis or plaque psoriasis. By specifically binding to TNF, etanercept blocks its activity, thereby reducing inflammation and other disease symptoms.
On a consolidated basis, Lupin reported a net loss of Rs 835 crore in Q3 December 2019 as against a net loss of Rs 151.75 crore in Q3 December 2018. Net sales declined 2.75% to Rs 3,716.09 crore in Q3 December 2019 over Q3 December 2018.
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Lupin is engaged in producing, developing and marketing a range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) across the world. The firm offers products in the cardiovascular, diabetology, asthma, pediatrics, central nervous system, gastro-intestinal, anti-infectives and non-steroidal anti-inflammatory drug therapy areas.
Shares of Lupin declined 2% to Rs 547 on Friday.
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